COPC BAND
FDA 510(k) clearance K021594 · decided 2003-11-13
Clearance details
- K-number
- K021594
- Device name
- COPC BAND
- Applicant
- Center For Orthotic and Prosthetic Care,Llc
- Decision
- Substantially Equivalent
- Date received
- 2002-05-15
- Decision date
- 2003-11-13
- Days to decision
- 547 days
- Clearance type
- Traditional
- Product code
- MVA
- Device class
- 2
- Regulation number
- 882.5970
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Arlington, VA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Talee, Talee PostOp (K241957) | Invent Medical USA, LLC | 2024-08-30 |
| Talee, Talee PostOp (K230444) | Invent Medical USA, LLC | 2023-06-22 |
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| Talee, Talee PostOP (K220681) | Invent Medical USA, LLC | 2022-09-22 |
| Hanger Cranial Band 3D (K203134) | Symbion Logistics, LLC | 2022-07-01 |
| MyCRO Band (K213587) | Otto Bock Healthcare LP | 2022-06-09 |
| SnugKap (K193383) | Headstart, Ltd. | 2021-06-07 |
| MyCRO Band (K201426) | Otto Bock Healthcare LP | 2021-03-26 |
| KidCap (K180568) | Eastern Cranial Affiliates, LLC | 2018-10-16 |
| STARBAND, STARLIGHT (K141842) | Orthomerica Products, Inc. | 2014-10-06 |
| STARBAND AND STARLIGHT (K140353) | Orthomerica Products, Inc. | 2014-06-06 |
| P-POD (K133397) | P-Pod | 2014-04-18 |
Recalls involving this device
No recalls on record reference this clearance.